## Job Details: Technical Documentation Specialist (Medical Devices & ISO 13485)Full details of the job.| | || --- | --- || | || | || --- | --- || | Australia || | Technical Documentation Specialist (Medical Devices & ISO 13485) || | VN421 || | Full-Time || | || | Production Quality || | The Technical Documentation Specialist is responsible for preparing and maintaining compliant medical device technical documentation, with clear evidence mapping and traceability across the product lifecycle.
- Supports new and commercial products, including technical files for new and legacy devices.
- Contributes to SDI Strategic Priorities and works safely in line with SDI's values of passion, accountability, respect, teamwork, and innovation. || |
- Prepare, review and maintain technical file documentation for new and legacy medical devices, ensuring content is clear, complete, evidence-based and suitable for regulatory submission or audit review.
- Ensure technical documentation demonstrates compliance with applicable requirements, including EU MDR Annex II/III, GSPRs, FDA 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP and relevant product standards.
- Develop and maintain traceability matrices linking regulatory requirements, GSPRs, design inputs/outputs, risks and controls, verification/validation evidence, labelling, claims and post-market data.
- Provide quality and regulatory input to submissions, technical documentation updates, design changes and product lifecycle activities.
- Collaborate with R&D, Manufacturing, Quality, Regulatory and Marketing to embed compliance requirements in relevant processes and documentation.
- Improve technical documentation templates, procedures and tools, including MDR evidence mapping and technical file traceability templates.
- Support Quality activities and ensure work is performed in accordance with the QMS, ISO 13485, MDSAP, EU MDR and other applicable requirements.
- Support risk management, design control and periodic standards review, including assessment of regulatory or standards changes that may impact products or technical documentation. || |
- External – Equipment suppliers, laboratories, research organisations, consultants and regulators.
- Internal – R&D, QA, QC, Regulatory Affairs, Manufacturing and Marketing. || | The position is located at Bayswater and Montrose Working hours: 38 hours per week || | Bachelor's Degree || |
- Degree in a scientific, engineering or related discipline.
- Experience in design control, risk management, verification/validation, document control and/or medical device technical documentation.
- Experience preparing or maintaining EU MDR technical documentation, including Annex II/III and GSPR evidence alignment.
- Practical understanding of EU MDR, ISO 13485, ISO 14971, MDSAP, FDA 21 CFR Part 820 and relevant IEC/ISO product standards.
- Experience with traceability matrices is highly regarded.
- 5+ years' experience in Regulatory Affairs, Quality Assurance or Research and Development is desirable.
- Proficient in MS Word, Excel, MS Project and other relevant computer software.
- Able to summarise complex technical and regulatory information clearly. || |
- Strong understanding of medical device technical documentation, manufacturing processes and quality management systems.
- Ability to structure technical files and traceability matrices that demonstrate compliance through objective evidence.
- Strong organisational skills, with the ability to prioritise tasks and support effective teamwork.
- Excellent technical writing and communication skills. || |
- Analytical, detail-oriented and quality-focused.
- Team-oriented and able to work effectively with cross-functional stakeholders.
- Able to work under pressure, reprioritise and meet deadlines.
- Self-motivated, accountable, flexible and reliable. || | Special || | AUD || | $80,000.00 || | $90,000.00 || | Per Annum || | Superannuation |
Technical Documentation Specialist (Medical Devices & ISO 13485) in Sydney employer: SDI Limited
SDI Limited is an exceptional employer located in Bayswater, Australia, offering a dynamic work environment that fosters innovation and collaboration. With a strong commitment to employee development, we provide ample opportunities for growth and advancement within the R&D field, alongside a supportive culture that values teamwork and creativity. Our focus on product quality and performance ensures that you will be part of meaningful projects that make a real impact in the industry.
